Last Updated: August 8, 2026

CLARITIN HIVES RELIEF Drug Patent Profile


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When do Claritin Hives Relief patents expire, and what generic alternatives are available?

Claritin Hives Relief is a drug marketed by Bayer Healthcare Llc and is included in three NDAs.

The generic ingredient in CLARITIN HIVES RELIEF is loratadine. There are thirty-nine drug master file entries for this compound. One hundred and fifty-five suppliers are listed for this compound. Additional details are available on the loratadine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Claritin Hives Relief

A generic version of CLARITIN HIVES RELIEF was approved as loratadine by PLD ACQUISITIONS LLC on January 21st, 2003.

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Recent Clinical Trials for CLARITIN HIVES RELIEF

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Andover Research Eye InstitutePhase 4
Rutgers, The State University of New JerseyEarly Phase 1
National Cancer Institute (NCI)Early Phase 1

See all CLARITIN HIVES RELIEF clinical trials

US Patents and Regulatory Information for CLARITIN HIVES RELIEF

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare Llc CLARITIN HIVES RELIEF loratadine SYRUP;ORAL 020641-003 Nov 19, 2003 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bayer Healthcare Llc CLARITIN HIVES RELIEF loratadine TABLET;ORAL 019658-003 Nov 19, 2003 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bayer Healthcare Llc CLARITIN HIVES RELIEF REDITAB loratadine TABLET, ORALLY DISINTEGRATING;ORAL 020704-003 Nov 19, 2003 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for CLARITIN HIVES RELIEF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 08C0004 France ⤷  Start Trial PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
1110543 SPC/GB08/005 United Kingdom ⤷  Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
0152897 C00152897/01 Switzerland ⤷  Start Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0152897 SPC/GB01/012 United Kingdom ⤷  Start Trial PRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

CLARITIN HIVES RELIEF market dynamics & financial trajectory (loratadine)

Last updated: June 25, 2026

Claritin Hives Relief is a branded, over-the-counter (OTC) antihistamine franchise built on loratadine 10 mg. The market is shaped by (1) intense OTC rivalry from cheaper store brands and competing non-sedating antihistamines, (2) pricing power constrained by frequent promotional cycles, and (3) recurring demand tied to seasonal allergy patterns plus persistent “itch/hives” use cases. Financial trajectory depends less on patent-driven life-cycle risk (the active is long off-patent) and more on distribution reach, brand spend efficiency, formulation line extensions, and share capture from newer OTC entrants.

What matters most commercially

  • IP and exclusivity: The loratadine molecule is not protected by meaningful active-use patents for OTC sale in the US. Competitive advantage is brand, formulation line management, and shelf presence, not exclusivity.
  • Channel economics: OTC antihistamines are high-volume, low-to-mid margin, and heavily promo-driven. Net sales skew toward mass retail, club, and online marketplaces with price compression.
  • Demand shape: Revenues follow allergy seasonality, with “hives/itch” demand creating incremental pulls during non-peak months (food/skin itch seasons, weather volatility, and chronic urticaria awareness).
  • Competitive substitution: Switchers can move quickly among OTC second-generation antihistamines with similar onset and “non-drowsy” claims, particularly if price differentials widen.

How big is the OTC loratadine antihistamine market for hives relief and what drives it?

Direct answer: Claritin Hives Relief sits in the broader OTC second-generation antihistamine market, driven by seasonal allergic rhinitis and incremental demand for itching and hive symptoms.

Key demand drivers

  • Seasonality: US allergy seasonality is the core driver. Loratadine sales typically rise in spring and early summer, and can show additional spikes with fall pollen and weather-related exposure.
  • Symptom adjacency: “Hives relief” usage captures consumers treating histamine-mediated itch rather than only nasal symptoms, increasing addressable demand when weather, allergens, or skin irritants are in play.
  • Consumer preference for “non-drowsy”: Second-generation antihistamines hold share because they reduce perceived sedation risk versus first-generation products (e.g., diphenhydramine).
  • OTC convenience: One-a-day dosing for loratadine increases adherence versus regimens that require more frequent dosing.

What OTC competitors pressure Claritin Hives Relief pricing and share?

Direct answer: Pricing and share are pressured by other non-sedating antihistamines and private-label versions, most notably cetirizine and fexofenadine OTC brands, plus store brands of loratadine.

Competitive intensity profile (US OTC)

  • Same class substitution: Consumers often switch within the “non-drowsy” class without perceiving clinically meaningful differences.
  • Private label: Store brands (including loratadine generics) typically undercut branded pricing, compressing promotional room for the brand.
  • Brand-to-brand price comparisons: When promotional spreads narrow, Claritin Hives Relief can lose incremental units to better-value alternatives.

Where Claritin typically differentiates

  • Brand trust and retail placement.
  • Package and messaging tied to “hives/itch relief” alongside allergy framing.
  • Persistent product line extensions and multi-pack bundles timed for seasonal demand.

When does Claritin Hives Relief lose exclusivity and how does that change its financial trajectory?

Direct answer: Active pharmaceutical ingredient (API) exclusivity for loratadine is long expired. The “exclusivity clock” affecting Claritin is therefore commercial, not legal: brand investment, shelf dominance, and promo intensity.

Why exclusivity is not the primary variable

  • Loratadine’s patent estate is not a meaningful constraint for OTC competitors.
  • Financial outcomes for Claritin Hives Relief depend more on:
    • distribution access and trade spend,
    • marketing efficiency,
    • price/mix management,
    • consumer switching behavior and retention.

What is the Orange Book status of Claritin Hives Relief?

No Orange Book assessment changes the competitive landscape for OTC loratadine hives relief, because OTC products generally are not evaluated via the FDA Orange Book exclusivity regime in the same way as prescription brand drugs. The relevant competitive framework is the OTC monograph and OTC NDA labeling/marketing rules rather than patent-listed Orange Book exclusivity controlling generic entry.

Which patents protect “Claritin Hives Relief” product conceptually in the US?

Direct answer: The brand’s protective moat is not primary API patents. For OTC loratadine tablets/caplets, any meaningful remaining protection would more often be limited to:

  • specific product formats, packaging, or marketing claims where legally protected,
  • potentially formulation/process patents if any were pursued for specific delivery formats (not the base 10 mg loratadine tablet concept).

In practice, for most OTC loratadine “hives relief” SKUs, the competitive threat is generic substitution, not patent expiry timing.

How do generic and store-brand entries change revenue and margin for Claritin Hives Relief?

Direct answer: Generic and private-label loratadine entries typically reduce branded unit share and compress net price through promotions and retailer pressure. The brand can partially offset volume loss through mix (packs, seasonal bundles) and maintaining promotional cadence, but gross margin typically trends down versus periods when brand pricing power is higher.

Expected financial mechanics in OTC antihistamines

  • Price compression: More aggressive private label and generic promos push down net pricing.
  • Trade terms expansion: To hold shelf, brands often increase retailer incentives, reducing net revenue per unit even when list price holds.
  • Mix management: Brands defend value through higher-count packs and seasonal bundles that may have slightly better margin mix than single-bottle sales.

What settlement or patent litigation affects Claritin Hives Relief?

Direct answer: For OTC loratadine “hives relief,” there is no patent-litigation-driven generic entry dynamic analogous to Paragraph IV events common in prescription brand launches. Competitive entry is structurally available once regulatory pathways and OTC market rules allow. The dominant mechanism is price competition from generics and private label rather than litigation outcomes.

What is the FDA regulatory status for “Claritin Hives Relief” and how does it affect commercialization?

Direct answer: As an OTC antihistamine, Claritin Hives Relief operates under OTC drug regulatory frameworks rather than FDA NDA exclusivity control. Regulatory status mostly impacts manufacturing compliance, labeling, and claim substantiation rather than driving delayed market entry for competitors.

Commercial implications

  • Entry barriers are modest relative to prescription drugs.
  • The brand’s competitive leverage is reduced to marketing, distribution, and consumer perception.

How does Claritin Hives Relief compare with Zyrtec and Allegra for financial performance drivers?

Direct answer: Zyrtec and Allegra frequently compete as second-generation “non-drowsy” leaders. Their financial outcomes tend to track promotional intensity, retailer shelf strategy, and consumer preferences for “symptom coverage” and perceived efficacy.

Comparison dimensions that affect sales trajectories

  • Perceived efficacy: Consumer perception can shift share.
  • Promo strategy: Temporary price cuts can swing units quickly across brands.
  • Symptom targeting: Products positioned for allergy vs itch/hives can shift mix depending on consumer needs in a given season.

What market dynamics control Claritin Hives Relief demand outside peak allergy season?

Direct answer: Demand persists due to itch/hives use cases and consumer stock-up patterns, but year-round performance is still driven by weather variability, household allergen exposure cycles, and acute skin-itch events.

Year-round demand levers

  • Urticaria awareness: OTC consumers may seek antihistamines for recurrent or episodic itching.
  • Household events: Pets, dust, and indoor allergens create off-season spikes.
  • Weather anomalies: Warm winters and rapid seasonal transitions increase pollen exposure and consumer usage.

How do retailers influence net sales and financial trajectory for Claritin Hives Relief?

Direct answer: Retailer mix and trade spend are central. OTC antihistamines are sold through mass channels where promotion intensity and shelf allocation can change net sales quickly.

Retail levers

  • Shelf space: Allocation to category leaders reduces space available for challengers.
  • Planogram discipline: Brands that can buy or earn shelf positioning preserve unit share.
  • Promotional calendars: Seasonal promotions often start earlier in warm years and extend longer.

What formulation, dosage, or packaging features drive revenue and repeat purchase?

Direct answer: In OTC antihistamine categories, consumer repeat is driven by perceived effectiveness and convenience. Loratadine’s once-daily regimen supports adherence.

Typical commercial levers

  • Value multipacks (multiple tablets in one purchase).
  • Calendarized seasonal bundles.
  • Retail visibility aligned with allergy shopping windows.

What revenue exposure does Claritin Hives Relief have to macro shocks and consumer trade-down?

Direct answer: If consumers trade down to store brands or lower-cost equivalents during macro pressure, branded net sales can decline faster than total category volume. OTC brands must use promotions to defend share, which can further compress margins.

Mechanisms

  • Lower discretionary spend shifts OTC purchasing to generics.
  • Retailers demand higher promotional contributions from brands for category share protection.
  • Value-seeking behavior increases unit elasticity.

Key financial trajectory summary (what drives upside vs downside)

Upside conditions

  • Strong allergy seasons and extended warm-weather windows.
  • Higher-than-category growth from itch/hives positioning.
  • Lower promo intensity relative to peers, or better trade terms.
  • Improved online sales share and conversion.

Downside conditions

  • Aggressive price competition from store brands and competing non-sedating antihistamines.
  • Retail shelf share loss during promo cycles.
  • Higher marketing or trade spend required to hold units.

Key Takeaways

  • Claritin Hives Relief’s market trajectory is governed primarily by OTC competition and pricing dynamics, not by patent exclusivity or FDA exclusivity.
  • Demand is seasonal with incremental “itch/hives” use that can support usage beyond peak allergy months.
  • Generic loratadine and private label compress net pricing, requiring brand investment to maintain share and manage mix.
  • Financial outcomes are most sensitive to promo intensity, retailer shelf allocation, and consumer switching within second-generation antihistamines.

FAQs

  1. How much do store-brand loratadine promotions typically reduce branded Claritin net pricing in mass retail?
  2. Do “hives relief” claims change consumer switching versus allergy-only positioning in OTC antihistamines?
  3. What are the biggest sales seasonality windows for second-generation antihistamines in the US and how do they impact quarterly trajectory?
  4. How does retailer online channel (marketplaces) alter price elasticity for OTC antihistamines like loratadine?
  5. Which OTC antihistamine is most likely to take share from loratadine during heavy promotion cycles: cetirizine or fexofenadine?

References

No inline sources were provided in the prompt, and no market/financial databases or FDA/Orange Book pages were cited; therefore no references can be listed.

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